Bharat Biotech Vaccine
Fair Pharma Scorecard
Applying human rights to pharma
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The company should publicly commit to human rights in relation to product development and marketing, by adopting an official human rights policy statement recognising the right to the highest attainable standard of health. The company should endeavour to integrate human rights into its strategies, policies, programmes, projects, and activities.
The company should also have a publicly available global access plan for their Covid-19 product, based on human rights standards, with measurable targets and lines of accountability.
CellTrion has not published a global access plan for its product.
Celltrion has a section on ‘social responsibility’ on its website, but does not mention human rights.
The company should constructively engage with international initiatives for the equitable distribution of vaccines and therapeutics, such as the Covid-19 Technology Access Pool (C-TAP) or the Medicines Patent Pool (MPP), and the ACT Accelerator (COVAX). The company should also publicly commit to not enforcing the exclusive rights of Covid-19 related patents, and enter into non-exclusive, transparent licensing agreements for its Covid-19 products with other companies.
Celltrion has not committed to C-TAP or the MPP, but was one of 18 generic companies that signed a pledge in November 2020 to work with the Medicines Patent Pool ‘to accelerate access to hundreds of millions of doses of new Covid-19 interventions for low- and middle-income countries’.
Celltrion has not committed to not enforcing the exclusive rights of Covid-19 related patents.
Celltrion has not signed an agreement with the ACT Accelerator.
Celltrion has not signed a licensing agreement yet, but has signed a pledge with the MPP which includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”
The company should engage in efforts to further equitable distribution of Covid-19 vaccines/therapeutics, by equitably distributing its supplies globally, devising fair pricing strategies, and making the active ingredient for its product available to other manufacturers. The company should also engage in full technology transfer to other manufacturers, including the necessary transfer of skills, legal components, knowledge and intellectual property. Where applicable, the company should agree to waive rights in regulatory test data, and refrain from enforcing TRIPS+ measures.
Celltrion has not made the active ingredient for its therapeutic available to other manufacturers so far. However, the MPP pledge states that “Previously, we have worked together by sourcing active pharmaceutical ingredients from each other and expanding distribution networks for finished formulations.” so we can hope that this means Celltrion will also apply this principle to Regdanvimab
Celltrion has not committed to full technology transfer yet, but its pledge with the MPP includes “working with MPP to negotiate licences for patented effective COVID-19 therapeutics, as they become available.” and “accelerating development and delivery timelines for new treatments with technology transfer support from MPP and originators, as needed.”
Celltrion has stated that “We plan to provide our treatment at a more affordable price than other monoclonal antibodies. In addition, the price will be negotiable based on the purchase volume by country.” Regkirona is priced at half the cost of Molnupiravir, and will be sold to domestic institutions at cost.
[Only applies to vaccines]
Celltrion’s pledge with the MPP is sufficient to infer that the company will not enforce TRIPS+.
Celltrion has not published any specific information in this regard, although the pledge with the MPP implies non-exclusivity.
The company should be as transparent as possible, by publishing its research and development costs, profit margin, average costs of production, and production capacity for its Covid-19 product. It should also disclose the amount of public subsidies received during product development and/or testing. Licensing agreements should also be made publicly available and clinical trials should be registered in public repositories.
Celltrion has only published very simplified financials on its website.
The company publishes its net profit, but this is not specific to Regdanvimab.
The costs of producing Regdanvimab are not published.
Celltrion states that it “expects the uptick in the number of coronavirus cases in Europe will affect the expansion of Regkinora supply”, but no specific production capacity number is mentioned. So far, it has distributed 150 000 doses to 9 countries and expects more supply orders soon.
Celltrion received 14.3 billion from the Korean government, which went mostly towards its antibody treatment. This is not published in its semi-annual reports, but Celltrion publishes other government grants received.
Celltrion has not published the texts of any licensing agreements.
Celltrion has registered its clinical trials on clinicaltrials.gov.
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